Safety and Tolerability of Cidofovir Gel Applied on Cervix Squamous Lesions

This study has been completed.
Sponsor:
Information provided by:
Mithra Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00989443
First received: October 2, 2009
Last updated: October 20, 2010
Last verified: October 2010
  Purpose

Human Papilloma Virus (HPV) infections induce cervical intraepithelial neoplasia (CIN) of cervix. To reduce incidence of invasive tumor associated with high grade CIN lesions, the standard treatment is the conisation of cervix (surgical act). A local treatment with the antiviral and anti-proliferative cidofovir would preserve the cervix of young subjects and reduce obstetrical morbidity induced by the conisation.

This clinical study is aimed at :

  1. evaluating the tolerance and safety of a cidofovir gel directly applied on the cervix exhibiting high grade CIN lesions;
  2. evaluating the pharmacokinetic (PK) profile of cidofovir after local application.

Condition Intervention Phase
Uterine Cervical Neoplasms
Cervix Intraepithelial Neoplasia
Drug: Cidofovir gel
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Clinical Study to Evaluate the Tolerance and Safety of an Aqueous Gel Containing 2% (w/w) of Cidofovir, Directly Applied on the Cervix Exhibiting High Grade Squamous Intraepithelial Lesion(s) (CIN 2 and 3)

Resource links provided by NLM:


Further study details as provided by Mithra Pharmaceuticals:

Primary Outcome Measures:
  • adverse events [ Time Frame: weeks 1, 2, 3 and 4 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 6
Study Start Date: May 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cidofovir Drug: Cidofovir gel
topical gel applied once a week for 3 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • women aged between 18 and 50 years old
  • volunteers
  • informed consent signed
  • cervical lesion classified CIN 2 or 3, on a biopsy made during the 6 preceding weeks
  • no sexual activity or use of effective mechanical, hormonal or intrauterine contraception (except hormonal vaginal ring)

Exclusion Criteria:

  • pregnancy or breast feeding
  • subtotal hysterectomy
  • current or ancient renal impairment
  • current immune disorder
  • current use of drugs interfering with renal function
  • current treatment for any cancer
  • current use of treatment interfering with immunity
  • current use of anti-viral treatment
  • current or recent participation to another experimental study during the last 3 months before the screening visit
  • current vaginal application of drugs or cosmetics
  • local or general condition incompatible with the experimental treatment in the opinion of the principal investigator
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00989443

Locations
Belgium
Erasme Hospital
Brussels, Belgium, 1070
Sponsors and Collaborators
Mithra Pharmaceuticals
Investigators
Principal Investigator: Michel Bossens, MD, PhD Erasme Hospital - Laboratoire de recherche en reproduction humaine
  More Information

No publications provided

Responsible Party: Dr. Michel Bossens, Erasme Hospital
ClinicalTrials.gov Identifier: NCT00989443     History of Changes
Other Study ID Numbers: MI-COL-CI01, EudraCT2009-012937-31
Study First Received: October 2, 2009
Last Updated: October 20, 2010
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Mithra Pharmaceuticals:
Cervix Intraepithelial Neoplasia grades 2 and 3

Additional relevant MeSH terms:
Neoplasms
Uterine Cervical Neoplasms
Cervical Intraepithelial Neoplasia
Carcinoma in Situ
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Cidofovir
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Anti-HIV Agents
Anti-Retroviral Agents

ClinicalTrials.gov processed this record on April 15, 2014